Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
- Conditions
- Low Birth WeightPrematurityInfant MalnutritionSmall for Gestational Age at Delivery
- Interventions
- Dietary Supplement: Fe and folic acid supplementDietary Supplement: Fortified balanced energy-protein (BEP) supplement
- Registration Number
- NCT03533712
- Lead Sponsor
- University Ghent
- Brief Summary
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.
- Detailed Description
Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation.
The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.
The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth.
This research includes 2 phases:
* Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement;
* Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.
* Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1788
- Participant age (15-40 years).
- Pregnant as determined by a pregnancy test and confirmed by ultrasound.
- Women who signed the informed consent form (in case of minors the parents or husband signs)
- Women planning to leave the area before delivery.
- Women who plan to deliver outside the area.
- Pregnancies with a gestational age > 20 weeks at study inclusion.
- Women with multi-fetal gestation (exclusion from analysis).
- Women who are allergic to peanuts.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Fe and folic acid Fe and folic acid supplement Dietary Supplement: Fe and folic acid supplement. Fortified BEP supplement Fortified balanced energy-protein (BEP) supplement Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement.
- Primary Outcome Measures
Name Time Method Small-for-Gestational-age (SGA) within 72h after birth Incidence of Small-for-Gestational-age (SGA) defined as \<10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
Length-for-age Z-scores (LAZ) at 6 months (and 12 months on a subsample) Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
- Secondary Outcome Measures
Name Time Method Head circumference within 72h after birth Child anemia at 6 months of age Hemoglobin concentration \<11g/dL
Child mortality between birth and 6 months of age Monthly change in WAZ over first 6 months of life Birth weight within 72h after birth Chest circumference within 72h after birth Neonatal mortality between birth and ≤ 28 days of life (1) Early neonatal mortality: deaths between birth and ≤ 7 days of life; (2) Neonatal mortality: deaths between birth and ≤28 days of life; (3) Late neonatal mortality deaths between \>7 days and ≤28 days of life
Ponderal or Rohrer's index' within 72 hours after birth Defined as birth weight/birth length3
Gestational weight change between study inclusion until 1 month after delivery Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
Child weight gain over first 6 months of life Monthly change in child weight
Birth length within 72h after birth Mid-upper arm circumference within 72h after birth Prenatal weight gain between study inclusion until just before delivery Weight change between study inclusion until just before delivery: total and trimester specific
Gestational age at delivery Preterm birth at delivery Incidence of preterm birth at \<37 weeks of gestation
Large-for-gestational age within 72h after birth Defined as a birth weight ≥90th centile intergrowth 21st reference
Fetal loss during pregnancy Fetal death at \<24 completed weeks of gestational age
Stillbirths during pregnancy Fetal death at ≥ 24 weeks gestational age
Women's minimum and mean dietary diversity score from study inclusion until delivery Measured biweekly using the 10 food group indicator as proposed by FAO. Minimum dietary diversity is defined as having consumed at least 5 food groups over the last 24 hours.
Weight-for-Age Z-score at 6 months of age WAZ, calculated using the WHO growth reference
Monthly change in LAZ over first 6 months of life Monthly change in head circumference over first 6 months of life Exclusive breastfeeding during the first 6 months of life Duration of exclusive breastfeeding
Monthly change in WHZ over first 6 months of life Underweight at 6 months of age Weight-for-Age Z-score (WAZ) \<-2, calculated using the WHO growth reference
Probable and possible maternal postnatal depression (1) at 2 months of child age; (2) at 6 months of child age Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS\>12. Possible depression is defined as EPDS\>9 .
Stunting at 6 months of age Length-for-Age Z-score (LAZ) \<-2, calculated using the WHO growth reference
Maternal anemia at the third antenatal consultation Hemoglobin concentration \<11g/dL
Weight-for-Length Z-score at 6 months of age WLZ, calculated using the WHO growth reference
Wasting at 6 months of age Weight-for-Length Z-score (WLZ) \<-2, calculated using the WHO growth reference
Incidence of child wasting over first 6 months of life Relative average telomere length At birth The umbilical cord blood will be analyzed to verify telomere length using qPCR on a sub-sample. Telomere lengths will be expressed as the ratio of telomere copy number to single-copy gene number (T/S) relative to the mean T/S ratio of the entire sample.
Child morbidity symptoms over first 6 months of life Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
Infant body composition first 3 months of life Sub-sample
Hemoglobin concentration at 6 months of age Maternal body composition first 3 months after delivery Sub-sample
Breast milk composition between 1-2 and 3-4 months Sub-sample
Trial Locations
- Locations (1)
Houndé district
🇧🇫Houndé, Tuy, Burkina Faso